Hand-held scanner systems and methods for reading point of care test results

ABSTRACT

A diagnostic assay system including a test device and a scanning device are described. In one implementation, the scanning device includes a source of electromagnetic radiation, an optics assembly, a detector, and a microprocessor disposed within a chassis. The test device and scanning device may be configured to be movable relative to each other during operation of the scanning device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. §119(e) to U.S.Provisional Patent Application Ser. No. 61/167,485, entitled HAND-HELDSCANNER FOR READING POINT OF CARE TEST RESULTS, filed on Apr. 7, 2009,the content of which is incorporated by reference herein in its entiretyfor all purposes.

FIELD OF THE INVENTION

This application is directed generally to systems, devices and methodsfor providing point-of-care testing. More particularly, but notexclusively, the present invention is directed to handheld test systemsand associated methods, including scanners and associated test devices.The test systems may be configured to provide portable, disposablepoint-of-care tests, as well as associated test processing, analysis andtest results and data.

BACKGROUND

Point-of-care test device readers and/or drive units are known in theart, such as those used for diagnostics of infectious diseases.Currently available readers are expensive and large (e.g., typicallyabout the size of an antique desk phone or similar device). In addition,they generally consume substantial amounts of power and are not easilyportable. For example, currently known readers are not readily capableof being placed in a user's pocket and/or taken from patient to patientat the bedside or point-of-care, making them cumbersome and expensive touse.

Accordingly, there is a need in the art for improved point-of-caretesting systems, devices and methods.

SUMMARY

The present invention is directed generally to devices and methods forproviding point-of-care test device readers.

In one aspect, a diagnostic assay system is disclosed, comprising: atest device including a test strip having one or more test lines and oneor more indicia; and a scanning device comprising: a source ofelectromagnetic radiation; an optics assembly disposed to direct theelectromagnetic radiation; a detector disposed to receive an emission orreflection from the test strip; a microprocessor; and a chassis; whereinthe test device and scanning device are configured to be movablerelative to each other during operation of the scanning device andwherein the microprocessor is configured to generate test result databased at least in part on the indicia and one or more of the test lines.

In another aspect, a method of assaying a sample to detect an analyte ofinterest is disclosed, the method comprising the steps of: providing asample from a sample collection device to a test device, wherein thetest device comprises one or more test lines having immobilized theretoa capture moiety specifically binding directly or indirectly one or moreanalytes of interest, and wherein the indicia are positioned on asurface of the test device adjacent the one or more test lines; movingthe test device relative to a scanning device so as to read one or moreof the test lines and one or more of the indicia; generating test resultdata based at least in part on the read of one or more of the indiciaand the one or more test lines; and storing the test result data in amemory.

In another aspect, a test device is disclosed, comprising a substrateincluding: a test strip having one or more test lines; and one or moreindicia; wherein the indicia are disposed on the substrate so at tofacilitate registration of the test device with respect to a scanner soas to compensate for presentation of the test device to the scanner.

In another aspect, a scanner is disclosed, comprising: a source ofelectromagnetic radiation; an optics assembly disposed to direct theelectromagnetic radiation; a detector disposed to receive an emission orreflection from a test device; a microprocessor; and a chassis; whereinthe microprocessor is configured to generate test result data based onone or more indicia associated disposed on the test device and one ormore test lines disposed on the test device.

In another aspect, a diagnostic assay system is disclosed. In variousembodiments, the diagnostic assay system includes a test device and ascanning device. The test device includes a test strip and indicia. Thescanning device includes a source of electromagnetic radiation, anoptics assembly, a detector, a microprocessor, and a chassis. A featureof the system is that the test device and scanning device are movablerelative to each other during operation of the scanning device. Incertain embodiments, the test strip includes one or more test lineshaving immobilized thereto a capture moiety specifically bindingdirectly or indirectly one or more analytes of interest as well asindicia wherein the indicia are positioned on a planar surface of thetest device adjacent the one or more test lines.

In another aspect, a method of assaying a sample is disclosed. Themethod may include one or more of: a) providing a sample to a samplecollection device; b) administering the sample from the samplecollection device to a test device, c) moving a scanning device acrossthe planar surface of the test device, and d) detecting the analyte ofinterest. In certain embodiments, the test device may include a lateralflow membrane and indicia. The lateral flow membrane may include one ormore test lines having immobilized thereto a capture moiety specificallybinding directly or indirectly one or more analytes of interest, as wellas indicia, wherein the indicia are positioned on a planar surface ofthe test device adjacent the one or more test lines. In certainembodiments, the scanning device may include a hand-held chassis,wherein disposed within the hand-held chassis may be one or more of anoptical energy source, an optics assembly, an optical energy detector,and/or a microprocessor. A kit including one or more of the test device,scanning device, and/or instructions for using the same is also providedherein.

Additional aspects and features of various embodiments of the inventionwill be apparent from the following description and appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention may be better understood in conjunction with theappended drawings. According to common practice, the various features ofthe drawings may not be presented to scale. Rather, the dimensions ofthe various features may be arbitrarily expanded or reduced for clarity.Included in the drawings are the following figures:

FIG. 1 illustrates a schematic view of an embodiment of a diagnosticsystem including a scanning device and a test device of the disclosure;

FIG. 2A illustrates an embodiment of a test device;

FIG. 2B is a distal end view of an embodiment of a scanning devicehaving an alignment system and light shield attached near the testdevice interface region;

FIG. 2C is a cross sectional view of the interface between the testdevice of FIG. 2A and the scanning device of FIG. 2B;

FIG. 2D is a cross-sectional view of another embodiment of an interfacebetween a test device and a scanning device;

FIG. 3 illustrates a schematic view of an example of the detection of ananalyte using an embodiment of the diagnostic system;

FIG. 4 illustrates an embodiment of a scanning device;

FIG. 5 illustrates a schematic view of the scanning device of FIG. 4;

FIG. 6 illustrates a schematic view of the optics assembly of anembodiment of a scanning device;

FIG. 7 illustrates an embodiment of a microprocessor sub-system for usein a scanning device;

FIG. 8 illustrates details of test sample scanning using a detector inaccordance with aspects of the present invention;

FIG. 9 illustrates a process for scanning and adjusting test results inaccordance with aspects of the present invention.

DETAILED DESCRIPTION

There is a growing need for implementations of hand-held systemsincluding test devices and scanners/readers that enable an operator toeasily read and record diagnostic test results. These systems may resultin reduced cost and power consumption as compared to current readers,which may more closely approximate the actual point-of-care. Inaddition, there is a need for readers that can be manufacturedinexpensively such that they can be used in a disposable manner or foruse, for example, in the third-world. Various embodiments of the presentinvention may be configured to address these needs as well as others.

Accordingly, disclosed herein are various embodiments of diagnosticassay systems that may include a reader (also denoted herein as ascanner), which may be configured to be handheld and relatively lowcost. The reader may be used for reading test results, such aspoint-of-care test results from a test device, of a sample, such as asample obtained from a human or animal patient or from a material orenvironment under test. The scanner may be configured to be portable,disposable, and easy to use. In certain implementations, the scanner maybe configured for use in conjunction with a test device, such as asubstrate, with the substrate including one or more indicia serving as apoint of reference for the scanning and/or reading of the test deviceand/or the analyzing and/or outputting of data representative of resultsobtained by said scanning and/or reading. The substrate may furtherinclude one or more test strips for receiving a sample.

In one aspect, a diagnostic assay system is disclosed, comprising: atest device including a test strip having one or more test lines and oneor more indicia; and a scanning device comprising: a source ofelectromagnetic radiation; an optics assembly disposed to direct theelectromagnetic radiation; a detector disposed to receive an emission orreflection from the test strip; a microprocessor; and a chassis; whereinthe test device and scanning device are configured to be movablerelative to each other during operation of the scanning device andwherein the microprocessor is configured to generate test result databased at least in part on the indicia and one or more of the test lines.

In another aspect, a method of assaying a sample to detect an analyte ofinterest is disclosed, the method comprising the steps of: providing asample from a sample collection device to a test device, wherein thetest device comprises one or more test lines having immobilized theretoa capture moiety specifically binding directly or indirectly one or moreanalytes of interest, and wherein the indicia are positioned on asurface of the test device adjacent the one or more test lines; movingthe test device relative to a scanning device so as to read one or moreof the test lines and one or more of the indicia; generating test resultdata based at least in part on the read of one or more of the indiciaand the one or more test lines; and storing the test result data in amemory.

In another aspect, a test device is disclosed, comprising a substrateincluding: a test strip having one or more test lines; and one or moreindicia; wherein the indicia are disposed on the substrate so at tofacilitate registration of the test device with respect to a scanner soas to compensate for presentation of the test device to the scanner.

In another aspect, a scanner is disclosed, comprising: a source ofelectromagnetic radiation; an optics assembly disposed to direct theelectromagnetic radiation; a detector disposed to receive an emission orreflection from a test device; a microprocessor; and a chassis; whereinthe microprocessor is configured to generate test result data based onone or more indicia associated disposed on the test device and one ormore test lines disposed on the test device.

In another aspect, a diagnostic assay system is disclosed. In variousembodiments, the diagnostic assay system includes a test device and ascanning device. The test device includes a test strip and indicia. Thescanning device includes a source of electromagnetic radiation, anoptics assembly, a detector, a microprocessor, and a chassis. A featureof the system is that the test device and scanning device are movablerelative to each other during operation of the scanning device. Incertain embodiments, the test strip includes one or more test lineshaving immobilized thereto a capture moiety specifically bindingdirectly or indirectly one or more analytes of interest as well asindicia wherein the indicia are positioned on a planar surface of thetest device adjacent the one or more test lines.

In another aspect, a method of assaying a sample is disclosed. Themethod may include one or more of: a) providing a sample to a samplecollection device; b) administering the sample from the samplecollection device to a test device, c) moving a scanning device acrossthe planar surface of the test device, and d) detecting the analyte ofinterest. In certain embodiments, the test device may include a lateralflow membrane and indicia. The lateral flow membrane may include one ormore test lines having immobilized thereto a capture moiety specificallybinding directly or indirectly one or more analytes of interest, as wellas indicia, wherein the indicia are positioned on a planar surface ofthe test device adjacent the one or more test lines. In certainembodiments, the scanning device may include a hand-held chassis,wherein disposed within the hand-held chassis may be one or more of anoptical energy source, an optics assembly, an optical energy detector,and/or a microprocessor. A kit including one or more of the test device,scanning device, and/or instructions for using the same is also providedherein.

Before additional details are further described, it is to be understoodthat the subject matter described herein is not limited to theparticular embodiments described, and as such may of course vary whilekeeping within the spirit and scope of the present invention. It is alsoto be understood that the terminology used here in is for the purpose ofdescribing particular exemplary embodiments only, and is not intended tobe limiting in any fashion, and in particular with respect to thedoctrine of equivalents. Unless defined otherwise, all technical termsused herein have the same meaning as commonly understood by one skilledin the art to which this subject matter belongs.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit, unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range, and any other stated or intervening value in thatstated range, is encompassed within the subject matter described herein.The upper and lower limits of these smaller ranges may independently beincluded in the smaller ranges, and are also encompassed within thesubject matter described herein, subject to any specifically excludedlimit in the stated range. Where the stated range includes one or bothof the limits, ranges excluding either or both of those included limitsare also included in the subject matter described herein.

It also noted that, as used herein and in the appended claims, thesingular forms “a,” “and,” and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to a“fastener” includes a plurality of such fasteners, and reference to “theengagement element” includes reference to one or more engagementelements and equivalents thereof known to those skilled in the art, andso forth.

It is further noted that the claims may be drafted to exclude anyoptional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like, in connection with the recitation of claimelements, or the use of a “negative” limitation. Accordingly, the term“optional” or “optionally present,” as in an “optional element” or an“optionally present element,” means that the subsequently describedelement may or may not be present, so that the description includesinstances where the element is present and instances where it is not.

As used herein, a “sample” is any material to be tested for the presenceand/or concentration of an analyte. In general, the sample may be anenvironmental, pathological, and/or a biological sample. For instance,in certain instances, the sample is a biological sample. A biologicalsample can be any sample taken from a subject, e.g., non-human animal orhuman, which sample, when obtained, may be used in a test deviceembodiment in accordance with the disclosure herein. For example, abiological sample can be a sample of any physiological and/or bodyfluid, cells, or tissue samples, such as from a biopsy or otherdiagnostic test.

Body fluid samples can include, without any limitation: blood, serum,plasma, urine, sputum, feces, semen, cervical mucus, vaginal or urethralsecretions, saliva or oral fluid, bile, cerebral fluid, nasal fluidincluding nasal swab or nasal aspirate, mucous, urogenital swab, spinalfluid, ocular lens fluid, sweat, milk, synovial fluid, peritoneal fluid,transdermal exudates, pharyngeal exudates, bronchoalveolar lavage,tracheal aspirations, cerebrospinal fluid, amniotic fluid, and the like.Herein, fluid homogenates of cellular tissues such as, for example,hair, skin and nail scrapings, and meat extracts are also consideredbiological fluids, etc. Biological samples can also include any samplederived from a sample taken directly from a subject, e.g., human. Forexample, a biological sample can be the plasma fraction of a bloodsample, serum, protein or nucleic acid extraction of collected cells ortissues. A biological sample can be from any subject, such as an animal,including but not limited to, human, bird, porcine, equine, bovine,murine, cat, dog or sheep.

A biological sample may be untreated or pretreated. Pretreatment of asample may involve, for example, preparing plasma from blood, dilutingor treating viscous fluids, and the like. Methods of treatment of asample can involve filtration, distillation, separation, concentration,inactivation of interfering components, and the addition of reagents.For example, a biological sample may be a specimen that has been treatedin a way to improve the detectability of the specimen or a componentwithin the specimen, such as a virus. For instance, the sample maycontain a nasal specimen that includes a virus, which specimen has beentreated with a lysis buffer containing a mucolytic agent that breaksdown the mucens in the nasal specimen, thereby significantly reducingthe viscosity of the specimen, and a detergent to lyse the virus,thereby releasing antigens and making them available for detection bythe assay.

Besides physiological fluids, other samples can be used such asenvironmental, dietary, and/or other samples, such as water, foodproducts, soil extracts, and the like for the performance of industrial,environmental, or food production assays as well as diagnostic assays.In addition, a solid material suspected of containing an analyte ofinterest can be used as a test sample. For instance, a sample that hasbeen modified to form a liquid medium, or modified to release theanalyte may be used. The selection and pretreatment of biological,industrial, and environmental samples prior to testing is well known inthe art.

As used herein, the term “exemplary” means “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

In certain instances, as is described in further detail herein, thedevices and methods of the disclosure may be used in the diagnosis of ahuman. However, the devices and methods disclosed herein may also beuseful for the diagnosis of veterinary diseases, analysis of meat,poultry, fish, e.g., for bacterial contamination, inspection of foodplants, food grains, fruit, dairy products (processed or unprocessed),as well as the inspection of a given environment, the cleanliness ofwhich is important, such as restaurants, hospitals and other publicfacilities. For instance, the devices and methods disclosed herein mayfind use in the analysis of environmental samples, including: water forbeach, ocean, lakes or swimming pool contamination. Analytes detected bysuch tests may include pathogenic agents, such as viral and bacterialantigens, as well as chemicals including, for example, lead, pesticides,hormones, drugs and their metabolites, hydrocarbons, and all kinds oforganic or inorganic compounds.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features that may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the spirit and scope of the subjectmatter described herein. Unless described otherwise, methods recitedherein may be carried out in the order of events recited or in otherorders that are logically possible. In addition, methods describedherein may be performed with more or fewer steps than specificallydescribed in some implementations.

EXAMPLE DIAGNOSTIC ASSAY SYSTEM

In one aspect, a system for the performance of a diagnostic assay isdescribed. Embodiments of the system may include a test device and/or ascanning device. For instance, a test device in conjunction with asuitable scanning device can be employed for the purpose of detecting ananalyte in a sample. In certain embodiments, a test device and/orscanning device may be provided for use in detecting and thereforedetermining the presence or absence of an analyte, such as a protein,nucleic acid, and/or small molecule, or the like, in a sample.

In various embodiments, the test device may be any type of device thatis capable of retaining a sample and further capable of being scanned bya scanning device, such as a scanning device/reader as described herein.In some embodiments, the test device may include a substrate, and thesubstrate may further include test strip and/or one or more indicia,such as are described in further detail below. In certain embodiments,the test device may include a housing, with the housing including alumen that may house the substrate. Additionally, in some embodiments,the substrate and/or housing may be configured for being removablycoupled to a sample collection device. In some embodiments, thesubstrate and/or housing and/or sample collection device may include abar code and/or text readable indication.

Therefore, in one aspect, the present disclosure is directed to a testdevice. In general, the test device can include one or more of: anoutside housing or casing, a cavity or lumen, defined by the housing, asubstrate and/or test strip, such as that described herein below. Theoutside casing or housing can form the body of the test device and aninterior substrate can also be included, wherein the substrate can forma test strip, as described below, which can be present within a lumen ofthe housing. The body can be made of any suitable material and caninclude a sample contacting portion and a read results portion. Forexample, the body of the test device can include a single or a pluralityof windows through which a portion, e.g., a read results portion, of asubstrate containing a test strip can be exposed.

In certain embodiments where a housing is included, the housing can alsoinclude one or more openings and/or windows. For instance, the housingcan include a proximal portion having a proximal end and a distalportion having a distal end, wherein an opening can be present e.g., ina proximal end of the device. The opening can be configured forreceiving a sample. Thus, the proximal portion of the device can bedenoted as the sample receiving portion. In certain embodiments, theopening can be configured for contacting and/or associating with aportion of a sample collection device (SCD), which device may beconfigured so as to removably couple to the test device, which couplingmay allow for the transfer of a sample, contained within the samplecollection device, from the SCD to the test device.

Accordingly, in certain embodiments, the opening is positioned above atest strip, with the opening configured such that upon joining with theSCD sample may be transferred to the test device from the SCD andcontacted with the test strip. For instance, in certain embodiments, theopening is configured to receive a distal end of a SCD, which distal endmay be configured to fit into or onto the opening. In certainembodiments, the test strip includes a wicking material which wickingmaterial may be positioned below the opening, e.g., at a samplecontacting portion of the test strip, and which wicking material isconfigured for receiving the sample when transferred. For example, theopening can be disposed directly above a wicking pad that is disposeddownstream of a test pad, which test pad can be positioned at a readresults portion of the test strip, as described below.

Furthermore, in some embodiments, a SCD and/or test device, as disclosedherein, can include one or more identifiable tags. In certain instances,the identifiable tags are removable and can be removed from one deviceand placed on another device. For instance, the test device can includean identity label such as a bar code, which identifies and/orcorresponds to an identical identity label on an SCD and can alsoidentify the lot number of the test device (e.g., for quality assuranceand tracking purposes).

In certain embodiments, the body of the test device does not include ahousing with a lumen. Rather, the test device includes only one or moreof a substrate and/or a test strip. As used herein, a test strip refersto the material to which a capture moiety (e.g., nucleic acid, protein,small molecule, metallic particle, nanoparticle, or the like) is linked,e.g., using methods known or developed in the art, and to which at leasta portion of the sample may be contacted. Accordingly, in someembodiments, the test device can include a substrate in conjunction witha test strip (which may or may not be contained within the housing of abody) such that together they are configured so as to form a matrix. Thematrix may define a flow path, such as an axial flow path. The matrixmay include several regions, such as a sample receiving or contactingzone, one or more test zones, and optionally, one or more control zones.In certain embodiments, a test region is included, wherein the testregion can include the test and control zones, which can be in the formof addressable lines, as described in greater detail herein below. Forexample, in certain embodiments, the test device includes a substrateupon which a test strip is associated. The test strip may, for instance,comprise a nitrocellulose membrane, such as a membrane that includes awicking pad, a test pad, and/or absorbent pad, such as where the wickingpad is proximal to the test pad and configured for receiving a sample,for instance, from a liquid sample collection device, and the absorbentpad may be positioned distal to the wicking and test pad, e.g., wherethe wicking and absorbent pads are separated by the test pad, and may beconfigured for absorbing the liquid sample and thereby causing thesample to flow from the wicking pad across the test pad and toward theabsorbent pad. It is to be noted, that a wicking and/or absorbent padmay not be included if desired, for instance, a membrane can be providedwherein the membrane is comprised of a single material such asnitrocellulose.

Accordingly, in certain embodiments, a substrate can be provided, whichsubstrate can be associated with one or more of a housing and/or a teststrip. A variety of materials can be used as a suitable substrate,including any material that can act as a support for the association ofa molecule of interest including, but not limited to organic orinorganic polymers, natural and synthetic polymers, including, but notlimited to, agarose, cellulose, nitrocellulose, cellulose acetate, othercellulose derivatives, dextran, dextran derivatives and dextranco-polymers, other polysaccharides, glass, silica gels, gelatin,polyvinyl pyrrolidone (PVP), rayon, nylon, polyethylene, polypropylene,polybutlyene, polycarbonate, polyesters, polyamides, vinyl polymers,polyvinylalcohols, polystyrene and polystyrene copolymers, polystyrenecross-linked with divinylbenzene or the like, acrylic resins, acrylatesand acrylic acids, acrylamides, polyacrylamide, polyacrylamide blends,co-polymers of vinyl and acrylamide, methacrylates, methacrylatederivatives and co-polymers, other polymers and co-polymers with variousfunctional groups, latex, butyl rubber and other synthetic rubbers,silicon, glass, paper, natural sponges, insoluble protein, surfactants,red blood cells, metals, metalloids, magnetic materials, or othercommercially available media or a complex material composed of a solidor semi-solid substrate coated with materials that improve thehydrophilic property of the test strip, for example, polystyrene, Mylar,polyethylene, polycarbonate, polypropylene, polybutlyene, metals such asaluminum, copper, tin or mixtures of metals coated with dextran,detergents, salts, PVP and/or treated with electrostatic or plasmadischarge to add charge to the surface thus imparting a hydrophilicproperty to the surface.

In certain embodiments, the substrate forms a matrix in the form of amembrane, as described above, wherein the matrix can be self-supporting.Other membranes amenable to non-bibulous flow, such as polyvinylchloride, polyvinyl acetate, copolymers of vinyl acetate and vinylchloride, polyamide, polycarbonate, polystyrene, and the like, can alsobe used. In yet another embodiment, the matrix may form a lateral flowmembrane that is composed of a material such as untreated paper,cellulose blends, nitrocellulose, polyester, an acrylonitrile copolymer,and the like. In one embodiment, the test strip substrate is treatedwith a solution that includes material-blocking and label-stabilizingagents. Blocking agents include bovine serum albumin (BSA), methylatedBSA, casein, acid or base hydrolyzed casein, nonfat dry milk, fishgelatin, or similar. Stabilizing agents are readily available and wellknown in the art, and can be used, for example, to stabilize labeledreagents.

As set forth above, the test device can include a test strip. Forinstance, the test device can include a substrate, with the substrateincluding a test strip. A test strip can be a portion of a substrate orcan be a membrane or other material that is associated with thesubstrate and/or housing, in which instance, the substrate can form abacking for the test strip. As used herein in the context of a testdevice, the terms “test strip,” “test membrane” or “lateral flowmembrane” may be used interchangeably, dependent on the context.

As indicated, in certain embodiments, the test strip can be a membrane,such as a lateral flow membrane, axial flow membrane, or can be formedas a matrix of one or more materials. In the present context, a lateralflow membrane can be configured so as to employ capillary action or toemploy the movement of fluid separate from capillary action, e.g., aswhere fluid is pumped by the accumulation of gas pressure, hydraulicpressure (direct pumping using a piston or rotary, bellows or other typepump on the assay fluids, electrostatic movement due to an electricfield), gravity, etc. to move or transport a sample, such as a testfluid.

Accordingly, the test strip, or a portion thereof, can be composed ofone or more of a variety of materials including, but not limited to alateral flow membrane of a porous material. For instance, in oneembodiment, a suitable test strip can be composed of a high densitypolyethylene sheet material, such as that manufactured by PorexTechnologies Corp. of Fairburn, Ga., USA. The sheet material can have anopen pore structure. For instance, the open pore structure can have adensity, at 40% void volume, of 0.57 gm/cc and an average pore diameterof 1 to 250 micrometers, the average generally being from 3 to 100micrometers. In an embodiment the test strip can be a nitrocellulosemembrane.

In certain embodiments, the disclosure provides a test device thatincludes a lateral flow test strip. As described above, the test stripcan include one or more zones or pads. For instance, in certainembodiments, the test strip can include a plurality of pads, such as asample pad, a test pad, and/or an absorption pad. For example, incertain embodiments, a sample pad containing an absorbent material canbe included wherein the sample pad is positioned downstream of a testpad. The test strip can additionally include an absorbent pad,containing a wicking material, which absorbent pad can be positionedupstream of the test pad. The lateral flow membrane can additionallyinclude a test pad, which test pad additionally includes a plurality ofaddressable lines, wherein each line can have immobilized thereto acapture moiety, such as a member of a specific binding pair, e.g., anucleic acid, protein, or the like, that is capable of binding with acorresponding moiety, such as a binding agent and/or an analyte ofinterest.

For example, in some embodiments, the test strip can include a test pador membrane substrate. The test pad can be comprised of a porousmaterial, such as a non-woven, spun-laced acrylic fiber, e.g., New Mergeor HDK material. The test pad can itself include one or more zones, suchas a test zone and a control zone (such as zones that are useful toverify that the sample flow is as expected). Each of the control zonescan include a spatially distinct region that can include an immobilizedmember of a specific binding pair that reacts with a labeled controlreagent. In one embodiment, the control zone can contain an authenticsample containing an analyte of interest, or a fragment thereof Inoperation, a labeled reagent can be restrained in each of the one ormore control zones. Thus in some embodiments, a test strip and/orsubstrate of a test device can be a test strip that includes a testmembrane that includes 1, 2, 3, 4, 5, 6, 7, 8 or more addressable testand/or control lines.

Upstream of the test membrane substrate can be a wicking substrate.Downstream of the test membrane substrate can be disposed anothersubstrate, such as an absorbent substrate. Suitable materials formanufacturing the absorbent substrate includes but are not limited to,hydrophilic polyethylene materials or pads, acrylic fiber, glass fiber,filter paper or pads, desiccated paper, paper pulp, fabric, and thelike. For example, the lateral flow membrane absorbent zone can becomprised of a material such as a non-woven, spun-laced acrylic fiber,i.e., New Merge (available from DuPont) or HDK material (available fromHDK Industries, Inc.), non-woven polyethylene treated to improve thehydrophobic property of the material. The test membrane substrate canoverlap or abut to one or both the wicking substrate and absorptivesubstrate, respectively.

Additionally, as set forth above, the test device may include one ormore indicia (also denoted herein in plurality as indicias). Forinstance, the test device can include a test strip and/or substrate,which test strip and/or substrate can include indicia. Indicia can be amarking or label or other form of reference or indication that iscapable of being read by a scanner or a component thereof. For instance,the indicia could be a magnetic, electronic or fluorescent marking orlabel, or the like, that is capable of emitting a signal that is capableof being read be the test device reader or scanner. The emitted signalmay be emitted in response to a received illumination, such as areceived electromagnetic illumination.

Therefore, in accordance with the devices and methods disclosed herein,a test device can be provided, wherein the test device is configured forbeing used for the receiving of a sample and for assisting in thedetection of an analyte (e.g., a target analyte of interest), present inthe sample. In certain embodiments, the test device includes a teststrip, which test strip can include a lateral flow membrane that may ormay not be associated with a substrate or other backing and may or maynot further be housed within a casing or body of the device. Thesubstrate and/or test strip and/or housing may be configured so as to becontacted by a sample and scanned and/or read by a scanningdevice/reader for detection of an analyte in the sample.

Accordingly, in one aspect, the present disclosure concerns a scanningdevice/reader. The scanning device can be any suitable scanning and/orreading device so long as it is capable of scanning and/or reading atest device, such as a test device described herein above, and/ordetecting the presence or absence of a signal thereon, which signal canbe indicative of the presence of one or more analytes in a sample beingtested and/or an indicia positioned on the test device. As used herein,a scanning device refers, generally, to an instrument for detectingand/or quantitating data or emissions, such as on or from test strips orindicia comprised in a test device. The data or emissions may be visibleto the naked eye, but does not need to be visible. For instance, incertain embodiments, the scanning device can be a reflectance and/orfluorescent based scanning device and/or text reader configured todetect emissions/reflections in the electromagnetic spectrum or atvisible or non-visible light wavelengths. Accordingly, in variousembodiments, the scanning device can be a reflectance, transmission,fluorescence, chemo-bioluminescence, magnetic, electromagnetic and/oramperometry scanner (or combinations of two or more of these elements),depending on the signal that is to be detected from the substrate, e.g.,of the test device (e.g., LRE Medical, USA). In one embodiment, thescanning device is an ultraviolet (UV) LED scanner that detects afluorescence signal.

The scanning device can include one or more of a source of energy, suchas electromagnetic radiation, an optics assembly, a detector and amicroprocessor, each of which may be enclosed in a housing or chassis.In various embodiments, any suitable energy source can be provided. Forinstance, in certain embodiments, the energy source can be a source ofelectromagnetic radiation. Any suitable source of electromagneticradiation can be used in the scanning device so long as the source ofelectromagnetic radiation is capable of emitting electromagneticradiation of a type that can be received by a detectable moiety, whichdetectable moiety is then capable of participating in the generation ofa detectable signal, e.g., fluorescence, in response to the receivedelectromagnetic radiation. For example, a suitable energy source caninclude one or more sources of electromagnetic radiation such as a laserdiode, light-emitting diode (LED), an LED array, or flashlamp. Theenergy source can emit light in the infrared, near infrared, ultravioletand/or visible wavelengths. The scanning device can additionally includean optics assembly.

The scanning device may also include a detector. Any suitable detectorcan be used so long as the detector is capable of receiving anddetecting an excitation signal that has been generated by a detectablemoiety in response to a received signal, such as a signal ofelectromagnetic radiation. For instance, a suitable detector can be onethat is capable of detecting a fluorescence signal, such as afluorescence signal that is excited by a light emitting diode of ascanning device, which light emitting diode emits a light in the UVregion of the optics spectrum and within the absorbance peak of thefluorescence signal (e.g., lanthanide label). For example, a suitabledetector can be a photomultiplier tube, photodiode, a PIN photodiode,silicone photodiode, differential photodiode, double diode, fourfolddiode, double wedge diode, circular ring diode, photo diode lines,matrix photo diode, PIN array, linear diode array (20-30 diodes),photodiode array (PDA). In certain embodiments, the detector can be acharge-coupled device (CCD), CMOS device, or LED photodiode. In oneembodiment, the diode is a UV laser diode. A conventional UV, LED orphotodiode can be used.

In some implementations, an imaging chip, such as a CCD or CMOS device,may be used to detect electromagnetic radiation, such as fluorescence,in one or two dimensions. In these implementations, the detector may beconfigured to provide a signal including a series of two dimensionalimage frames or one dimensional lines collected from scanning a testsample over time. For example, a test sample may be passed across thesensor and the series of frames or lines sent to a computer module (asfurther described herein) to determine speed of the sample read, speedvariations in the sample presentation, detect and correct for angularoffsets in the sample presentation, and/or provide other processing toregister or reference the sample, such as in conjunction with indicia,to a reference position or location. The detector may be configured todetect electromagnetic radiation over a range of wavelengths and/or mayinclude a filter or other configuration to limit detection to a discretewavelength or range of wavelengths.

The scanning device may additionally include one or more filters. Forinstance, where the scanning device is configured for scanning anddetecting an emitted fluorescent signal, the emitted fluorescence signalmay be detected by a photodiode, with the wavelength of the detectedsignal then limited using a long pass filter which blocks stray emittedlight and accepts light with wavelengths at and around the peak emissionwavelength of the fluorescence emitting label. In other embodiments, thelong pass filter may be replaced by a band pass filter. Furthermore, theexcitation light may be limited by a band pass filter.

The scanning device may additionally include a computer module that mayinclude, for example, one or more embedded microprocessors,microcontrollers, DSP devices, ASICs, FPGAs or other programmabledevices (referred to collectively herein as a “microprocessor”) andassociated memory that may be physically separate from and/orincorporated in the microprocessor. The computer module will generallyinclude one or more memory spaces configured to store instructions forexecution on the microprocessor to direct the computer to scan a testsample and determine positional information and/or motion informationassociated with the sample scan. In addition, the instructions mayinclude instructions for processing the test sample for detection of ananalyte, such as is further described below. The microprocessor, as isdescribed in greater detail herein below, can include or be controlledby processor executable instructions comprising data processing softwaremodules, which software modules can employ data reduction and curvefitting algorithms, optionally in combination with a trained neuralnetwork for accurately determining the presence and/or concentration ofanalyte in a biological sample. In addition, the software modules mayinclude instructions to detect position and/or movement information ofthe sample with respect to the scanner/reader. This detection may bebased on detecting sample emissions or reflections as well as emissionsor reflections from one or more indicia. The position and/or movementinformation may be used to adjust or correct the analyte detectionresults.

Exemplary software modules may include curve fitting algorithms,optionally in combination with software configured for compensating forambient light and/or other background noise, to determine the presenceor amount of an analyte in a given sample. The data obtained from thescanning device then can further be processed by a diagnosis systemprogram or a person capable of reading the output of the data so as toprovide a risk assessment or diagnosis of a medical condition as output.In alternative embodiments, the output can be used as input into asubsequent decision support system, such as a neural network, that istrained to evaluate such data. The scanning device may additionallyinclude one or more physical memory devices and/or may include one ormore of a receiver for receiving remote commands, e.g., from an externalcomputer, and/or a transmitter for transmitting data, e.g., to anexternal computer, which data may be transferred wirelessly by a carriersuch as an RF frequency, IR radiation, blue-tooth, or the like, or maybe transferred using a suitable connector, such as a wire or cable. Incertain embodiments, the scanning device may also include a USB port orother communications port for directly associating and/or communicatingwith an external computer. This may be implemented by incorporating orusing external wireless connectivity elements such as IEEE 802.11(Wi-Fi) component or module, Bluetooth component or module otherwireless networking component or module.

As mentioned above, the scanning device may include a suitable housingor chassis. The chassis can be formed of a generally rigid, preferablypolymeric material, such as polyvinyl chloride or some other suchpolymeric material known to those of ordinary skill in the art. In anexemplary embodiment, the chassis can be configured to be of dimensionssuch that the chassis can be held in a user's hand or placed in a user'spocket. The chassis may include an interface region having a slit oraperture through which energy may be directed, e.g., towards the testdevice during use. The chassis can include an actual keyboard or avirtual keyboard, for instance, as present on a touch screen display.The keyboard may include a plurality of actuators or keys, including apower on/off key, scan key, cancel key, enter key, alphanumeric keys orother keys on a keypad or touch-screen, and the like. The keys maypermit a user to communicate with the instrument as with other hand-heldinstruments. The housing can include a display, such as an LED or LCDdisplay, and/or a printer. The chassis can include a removable coverthat encloses output ports or other data ports and the like. The dataport can be configured to accept removable memory devices such as USDdrives, SD, memory stick, compact flash or other memory cards, or othersimilar devices. The chassis can also include an alignment system and/orlight shield, such as that surrounding an interface region.

As set forth above, the scanner and/or reader may be configured forinteracting with a test strip and/or substrate containing a detectablereaction product of the disclosure and/or an indicia, which test stripand/or substrate can form part of a test device, as described herein.For instance, in one embodiment, the scanner can include a receivingport designed to receive a substrate and/or a test device including asubstrate. In certain embodiments, the receiving port may be such thatthe test device can only be inserted into the receiving port if adepressible (e.g., push button) means upstream of a sample entryaperture has been depressed, thereby allowing the test device to fitinto the receiving port in whole or in part. In certain embodiments, thescanner is adapted with a receiving port for a test device. In certainembodiments, the scanner is configured for scanning and/or reading atest strip without physically engaging the test device. Accordingly, insuch an implementation, the scanner does not include a receiving port.

Attention is now directed to FIG. 1, which illustrates details of oneembodiment of a diagnostic assay system 10 in accordance with thepresent invention that includes a scanning device 15 and a test device20, each to be described in more detail below. The test device 20 andthe scanning device 15 may be configured so that they can each behand-held, battery powered, and therefore easily portable. The scanningdevice 15 can include one or more of an energy emission source, such asa source of electromagnetic radiation 25, an optics assembly 30, adetector 35, and a microprocessor 40 (on a circuit board or othermounting configuration 43, typically accompanied by one or more memorydevices and other electronic components (not shown)), and/or a chassis45, to be described in more detail below. The chassis 45 of the scanningdevice 15 can be configured to be of dimensions such that the chassiscan be held in a user's hand, and can include an interface region 50that can be positioned near the distal end of the chassis 45. Theinterface region 50 can include a slit or aperture 55 (also shown inFIG. 4 as 255) through which energy from the energy source 25 can bedirected, e.g., towards the test device 20 during use.

The test device 20 can include a substrate 5, which substrate 5 mayinclude a housing 7, an opening configured for receiving a portion of asample collection device 9, and may further include a diagnostic lane60. The diagnostic lane 60 may have a test strip 65, to be described ingreater detail herein below, and can have adjacent reference marks orindicia 70. The test strip 65 in the diagnostic lane 60 can includebound capture moieties that can interact with analyte in a fluid sample,e.g., obtained from a patient, when contacted with the sample, orportion thereof

For instance, in an exemplary embodiment, a test strip 65 includescapture moieties that are fixed to the surface of the test strip 65 atpredetermined locations. The capture moieties can be configured suchthat they specifically interact with an analyte, or a portion thereof,in the sample so as to bind thereto and immobilize the analyte at thepredetermined locations. In certain instances, the sample has beenpreprocessed such that any analyte present therein becomes labeled. Thepresence of the label functions to allow the analyte that has beenimmobilized at the predetermined location to be detected.

As mentioned above, the substrate 5 may include one or more referencesmarks or indicia 70. The indicia 70, which can be adjacent thediagnostic lane 60, can likewise be read by the scanning device 15 andcan act as reference points so as to allow the scanning device 15 toread and interpret the read information. The indicia 70 may be read bythe scanning device simultaneously with test lines 267 (furtherillustrated and described with respect to FIG. 2) in the diagnostic lane60. The indicia 70 may act as reference points and providestandardization to interpret the orientation of the device thereby toensure accuracy of the reads. In certain embodiments, an indicia is nota labeled analyte, such as an analyte present in a sample to be read. Asshown in FIG. 1, the indicia are in the form of circles or dots,however, in various embodiments they may be provided in different shapesand/or surface features, such as raised textures.

For reading purposes, the scanning device may include a separate channelor use a separate wavelength or detector or processing algorithm inorder to interpret a read. As described below, the scanning device caninclude a separate channel or use a separate wavelength or detector oralgorithm in order to interpret and/or otherwise use the data from thetest strip(s) and/or indicia 70. In an exemplary embodiment, therelative movement and angle between the test device and the scanner canbe standardized and corrected for according to detection of the indicia70 on the test device and in some instances, a label from an analyte ina test sample to be read. The indicia 70 can also inform the scanningdevice when a test line in the diagnostic lane 60 is to be read, forexample when the scanning device is lined up with each test line in thediagnostic lane 60.

In typical embodiments, the test device 20 can interact with thescanning device 15 in such a manner that the scanning device is able to“read” the test strip 65, detect the labeled and immobilized analytetherein, and thereby provide information about the analyte of interest.The test device 20 and scanning device 15 can be configured such thatthe two devices are freely movable relative to each other, e.g., in atleast one plane. The test device 20 and scanning device 15 can also beconfigured so as to be freely movable in more than one plane. In someembodiments, the test device 20 need not be inserted into the chassis 45of the scanning device 15 to accurately read the results of the testdevice 20. It is noted that in certain instances, the chassis 45 of thescanning device 15 can be configured such that the test device 20 can bereceived therein. In addition, the chassis 45 may be configured so thatthe test device 20 may be mechanically aligned and/or locked with thescanning device 15 during reading. However, due to the uniqueconfiguration of the present system, this need not be the case.

In conjunction with standardization and correction for the relativemovement and angle between the test devices and test samples and thescanners, e.g., via correction software modules as are described herein,there are a variety of ways in which a read can take place. In oneembodiment, the test device can be stationary, for example, sitting on atabletop, and the scanning device can be mobile, for example, held in auser's hand, such that the scanning device is passed across a diagnosticlane and/or indicia of a test device to obtain a reading. In anotherembodiment, the scanning device may be stationary and the test devicemay be mobile, for example, held in a user's hand, such that the testdevice is passed in front of an interface region of the scanning deviceto obtain a reading. In another embodiment, both the test device and thescanning device can be mobile, for example each may be held in a user'shands during a reading. The relative movement and angles between thetest device and the scanning device may be standardized and correctedfor according to detection of the indicia and/or label on the testdevice and/or the test strips, and calculations made by a softwarealgorithm or algorithms implemented in one or more software modules.

EXAMPLE TEST DEVICE

As described above, the disclosed diagnostic assay system may include atest device and a scanning device, which devices may be used inconjunction with one another so as to detect one or more analytes ofinterest in a sample, which sample can be processed by the test deviceand which analyte can be detected by the scanning device. In someimplementations, the test device and scanning device may be provided asseparate embodiments, each configured to provide at least part of theircorresponding functionality as described herein.

Turning to FIG. 2A, one embodiment of the test device 220 may include atest strip 265 having one or more test lines, dots or other shapes 267.The test lines 267 may be areas in which a capture moiety is bound suchthat analyte of interest can be captured and “read” with the scanningdevices described herein.

As used herein in the context of a test device, the terms “test strip”or “test membrane” or “lateral flow membrane” are used interchangeably.The test strip 265 can be a lateral flow membrane, axial flow membrane,or matrix. In an embodiment the test strip 265 may be a nitrocellulosemembrane. The test device 220 may include a substrate with a housing orother body 505 or a material with which the test strip 265 isassociated. The test strip 265 can include a capture moiety, whichcapture moiety can be linked to the test strip at a predeterminedposition using methods known in the art.

For instance, in one embodiment, the test device 220 may include a teststrip 265 disposed within a housing or body of a substrate 505 (see, forexample, FIG. 2A). The body 505 can include a window 510 or plurality ofwindows near the diagnostic lane 260 through which the test strip 265 isexposed. The body 505 can also include a port or opening 515 to which asample collection device can be affixed and sample delivered to the testdevice 220 for analysis. It should be appreciated that the test device220 need not include a body 505. The body 505 of the test device may becomposed of rigid or semi-rigid, non-water-permeable material such asglass, ceramic, metal, plastic, polymer, copolymer or combinationsthereof. The body 505 can also function as an adapter for reading a teststrip 265 directly with the scanning device.

As mentioned above, the body 505 of the test device 220 can includefeatures that can interface with a scanning device, such as a scanningdevice described herein below. For example, as can be seen with respectto FIG. 2B, if the scanning device 215 includes an alignment system 257,the body 505 of the test device can have complementary alignmentfeatures 272 that interface with the alignment system 257 of thescanning device. As best shown in FIGS. 2A-2D, the alignment system 257of the scanning device can be, for example, a pair of parallel railspositioned on either end of the aperture 255 near the interface region250 (see FIG. 4) of the device 215. Such an alignment system 257 can,for example, slideably interface with corresponding alignment features272 present on the surface of the test device 220. The alignmentfeatures 272 of the test device 220 can be, for example, a pair oflongitudinal channels. Alternatively, the alignment features 272 of thetest device 220 can include raised tracks over which the alignmentfeatures 272 of the scanning device 215 are guided during a swipe (seeFIG. 2D). The configuration of the alignment system 257 andcorresponding alignment features 272 can vary. It should also beappreciated that the scanning devices described herein and the testdevice need not mechanically couple. Even if an alignment system 257 isincorporated in the scanning device, the test device and scanning devicemay be independently and freely movable relative to each other.

As described above, the body 505 or test strip 265 may include referencemarks or indicia 270 positioned adjacent the diagnostic lane 260. As setforth above, such indicia may be detectable independently from a labeledanalyte within a sample to be read. The indicia 270, however, maylikewise be read by the scanning device, such as simultaneously with thetest lines 267, and may act as reference points and providestandardization to interpret the orientation of the read direction andso as to ensure the accuracy of the read(s). The indicia may also beused to correct for variation in presentation angle and/or sample speedwith respect to the scanner.

As described below, the scanning device can include a separate channelor use a separate wavelength or detector or algorithm in order tointerpret and/or otherwise use the data or emissions from the indicia270. Accordingly, the relative movement and angle between the testdevice and the scanner can be standardized and corrected for accordingto detection of the indicia 270 on the test device. The indicia 270 canalso inform the scanning device when a test line 267 is to be read, forexample when the scanning device is lined up with each test line 267.

The indicia 270 can be printed directly on the test device 220, integralwith the test strip 265 or attached to the device such as by removablestick-on labels. The indicia 270 can form a pattern. For example, thepattern can be in 1, 2 or 3 dimensions. The pattern may be used tocorrelate the indicia readings in the scanner with a known referencepattern so at to adjust the read data responsive to the correlation.This may be done in a software module of the scanner in conjunction witha microprocessor, such as microprocessor 40.

In one embodiment, the indicia 270 can be a labeled reference point suchas a Europium label or other detectable label. The indicia 270 can be ingray scale or in color. In one embodiment, the indicia 270 form atwo-color pattern. The indicia 270 can also be raised bumps,indentations, or metal electrodes in the body 505, which be detectedmechanically or electrically with the scanning device 215. For example,the scanning device 215 can have electrodes on one or more sides thatcome in contact with the electrodes serving as the indicia 270.Alternatively, the scanning device 215 can have hinged or bendable flapsextending downward from its bottom side, which deflect as they pass overthe bumps serving as the indicia 270 or which move downward as they passover the indentations serving as the indicia 270. Such flaps can beconnected to leads, which can carry an electrical signal as the flapsdeflect or move in a certain direction.

As shown in the schematic of FIG. 3, the test strip 265 within thediagnostic lane 260 can include one or more test lines 267. The testlines 267 may be areas to which a capture moiety 605 is immobilized forcapturing an analyte of interest 610 from a fluid sample. The capturemoiety 605 binds either directly or indirectly to the one or moreanalytes of interest 610 from the fluid sample. Indirect binding such asthrough sandwich immunoassay techniques as known or developed in the artcan be incorporated. Indirect binding of an analyte of interest 610involves the use of a binding agent such as a capture antibody orcapture probe 615 that is immobilized on the capture moiety 605. Adetection probe 620 refers to a binding agent that captures an analyteof interest in the fluid sample and is linked to a detectable label 625,moiety or signal producing moiety. The capture probe 615 and detectionprobe 620 are each capable of specifically binding to a target analyte610.

The test strip 265 can also include a control line or spot (not shown).The control line can confirm that a sufficient amount of capturemoieties 605 could react with the corresponding capture probe 615complexed to a specific analyte 610. Control reagents can confirm thatthe immunocomplexes migrate onto the diagnostic lane 260 and cross thetest line 267 in an amount that the accumulation of labeled analyte 610would produce a visible or otherwise readable signal in the case of apositive test result.

Capture moiety 605 can include one or more of a binding pair as known inthe art such as avidin and/or streptavidin, as well as pyranosyl RNA(pRNA), oligonucleotide, aptamer, modified nucleic acid, nucleic acidpyranosyl-RNA sequence, nanoparticle, polypeptide, protein, antibody orcombination thereof (see PCT Publication Nos. WO07098184 and WO09014787,which are incorporated herein by reference in their entirety, forexamples of binding pairs, capture moieties, and labels). Additionalcapture moieties or combination of capture moieties can be used as areknown in the art. Accordingly, capture probe 615 and detection probe 620can include antibodies, aptamers, oligonucleotides, and the like.Additional probes or combination of probes can be used as is known inthe art.

The label 625 can be any substance capable of producing a signal that isdetectable by visual or instrumental means. Exemplary labels 625 caninclude enzymes, substrates, chromagens, catalysts, fluorescent orfluorescent-like compounds and/or particles, magnetic compounds and/orparticles chemiluminescent compounds and/or particles, and radioactivelabels. Other suitable labels include particulate labels such ascolloidal metallic particles such as gold, colloidal non-metallicparticles such as selenium or tellurium, dyed or colored particles suchas a dyed plastic or a stained microorganism, organic polymer latexparticles and liposomes, colored beads, polymer microcapsules, sacs,erythrocytes, erythrocyte ghosts, or other vesicles containing directlyvisible substances, metals, fluorophores, chromophores, Europium or anycombination thereof. Additional labels or combination of labels can beused as are known or developed in the art.

Target analytes of interest to be assayed by the system disclosed hereincan vary. As used herein the term “analyte” or “analytes” refers to thecompound or composition to be detected or measured and which has atleast one epitope or binding site. The analyte can be any substance forwhich there exists a naturally-occurring or synthetic analyte-specificbinding member or for which an analyte-specific binding member can beprepared, e.g., carbohydrate and lectin, hormone and receptor,complementary nucleic acids, and the like. Further, possible analytesinclude virtually any compound, composition, aggregation, or othersubstance which can be immunologically-detected. That is, the analyte,or portion thereof, may be antigenic or haptenic having at least onedeterminant site, or will be a member of a naturally occurring bindingpair. In other embodiments, one or more analyte detected is an antibody(e.g., IgG, IgM) in a sample (e.g., urine, oral fluid, blood, plasma orserum sample) where the antibody is specific for a virus or viruscomponent, bacteria or bacteria component, cancer cell or tumor antigen.For example, by detecting one or more antibody, the assay indicates thatthe patient has been previously infected by an infectious agent orsuffers an underlying condition with which the antibody is associated.In further embodiments, allergy detection testing comprises detectingthe presence of specific IgG, IgM and/or IgE Ab in a subjects oralfluid, whole blood, urine, plasma or serum to specific allergens.

Analytes of interest can include toxins, organic compounds, proteins,peptides, microorganisms, bacteria, viruses, yeast, fungus, parasites,cancer cell, amino acids, nucleic acids, modified nucleic acids,polypeptides, proteins, antibody, derived from an infectious agent,carbohydrates, hormones, steroids, vitamins, drugs (including thoseadministered for therapeutic purposes as well as those administered forillicit purposes), pollutants, pesticides, and metabolites of orantibodies to any of the above substances, antigenic substances,haptens, macromolecules, and combinations thereof. Other analytes ofinterest can include Influenza A, influenza B, seasonal influenzasubtypes (H1N1 and H3N2), and pandemic influenza subtype H5N1, BNP,NT-proBNP, proBNP, CNP, ANP, RSV, adenovirus, upper respiratoryinfection panel, Streptococcus pneumoniae, mycoplasma pneumonia, HIV,HCV antigens, tuberculosis, SARS-associated coronavirus, hepatitis panelcomprising a selection of hepatitis B surface Ag or Ab, hepatitis B coreAb, hepatitis A virus Ab, and hepatitis C virus; a phospholipids panelcomprising a selection of Anticardiolipin Abs (IgG, IgA, and IgMIsotypes); an arthritis panel comprising a selection of rheumatoidfactor, 15 antinuclear antibodies, and Uric Acid; an Epstein Barr panelcomprising a selection of Epstein Barr Nuclear Ag, Epstein Barr ViralCapsid Ag, and Epstein Barr Virus, Early Antigen; other panels includeHIV panels, Lupus panels, H. Pylon panels, toxoplasma panels, herpespanels, Borrelia panels, rubella panels, cytomegalovirus panels, panelstesting for recent myocardial infarction or congestive heart failure,such as analytes comprising an isotype of troponin, myoglobin,natriuretic peptide (e.g., ANP, pro-ANP, BNP, pro-BNP, CNP, NT-proBNP,etc.), D-dimer, and/or CKMB, one or more virus or virus components, oneor more bacterial or bacterial components, one or more cancer cell orcancer cell components, one or more analytes associated with a conditionsuch as a brain condition, damage or disease, heart condition, damage ordisease, cancer or neoplastic condition, or disease, liver condition,damage or disease, kidney condition, damage or disease, or a combinationthereof

In various embodiments, the analyte(s) detected are associated with aninfectious agent. An infectious agent can be any pathogen includingwithout any limitation bacteria, yeast, fungi, virus, eukaryoticparasites, etc. In some embodiments, the infectious agent is influenzavirus, parainfluenza virus, adenovirus, rhovirus, coronavirus, hepatitisviruses A, B, C, D, E, etc, HIV, enterovirus, papillomavirus,coxsackievirus, herpes simplex virus, or Epstein-Barr virus. In otherembodiments, the infectious agent is Mycobacterium, Streptococcus,Salmonella, Shigella, Staphylcoccus, Neisseria, Clostridium, or E. coli.It will be apparent to one of skill in the art that different infectiousagents can be detected using a different panel of binding agents (e.g.,antibodies) that are specific for type(s) or subtype(s) of an infectiousagent(s).

EXAMPLE SCANNING DEVICE

FIGS. 4 and 5 illustrate an exemplary embodiment of a scanning device215. As mentioned above, the scanning device 215 may include an energyemission source 225, an optics assembly 230, a detector 235, and amicroprocessor 240 and associated memory, each disposed within a chassis245. The scanning device 215 may be configured so as to be easilyportable, may be battery powered, may be capable of being held in auser's hand and may be small enough to be placed in a user's pocket.Near the distal portion of the chassis 245 is an interface region 250having an aperture 255 through which the scanning device 215 reads atest device containing a diagnostic lane, as described in more detailbelow. To perform a reading of a test device, the chassis 245 is sweptover the diagnostic lane of the test device with the interface region250 pointed towards the diagnostic lane. The chassis 245 of the scanningdevice 215 may be configured to be freely moved by the user with respectto the test device and vice versa. In certain embodiments, the testdevice is not inserted or loaded into the chassis 245 of the scanningdevice 215.

The scanning device 215 may include one or more energy emission sources225 such as an electromagnetic radiation source that emits light toexcite a labeled sample immobilized at a test line 267 of the test strip265. The energy source 225 can include one or more sources ofelectromagnetic radiation such as for example a laser diode,light-emitting diode (LED), an LED array, a flashlamp, and/or othersources as are known or developed in the art. The energy source 225 canemit light, for instance, in the infrared, near infrared, ultravioletand visible wavelengths. The light emitted by the source 225 can betuned to a specific frequency or range of frequencies or set offrequencies or ranges of frequencies. In an embodiment, the device 215includes a plurality of energy sources 225. In a further embodiment, thedevice 215 includes an array of energy sources 225.

The scanning device 215 may also include one or more detectors 235. Thedetector 235 may be configured to detect, capture and/or sense light,fluorescence or other electromagnetic energy reflected or emitted fromthe direction of the diagnostic lane 60 of the device 215 and provide acorresponding output signal. For example, the detector 235 can detectlight emitted from a labeled analyte in response to excitation energyfrom the energy source 225. The detector 235 can be optimized such thatit detects for example, Europium or another label. In one embodiment,the device 215 includes a plurality of detectors. In a furtherembodiment, the device 215 includes an array of detectors.

The detector 235 can be a photomultiplier tube, photodiode, a PINphotodiode, silicone photodiode, differential photodiode, double diode,fourfold diode, double wedge diode, circular ring diode, photo diodelines, matrix photo diode, PIN array, linear diode array (20-30 diodes),photodiode array (PDA). In an embodiment, the detector 235 can be acharge-coupled device (CCD), CMOS device or LED photodiode. This type ofdetector employs an array of tens, hundreds or thousands of tiny lightsensors lined up in a row. Each sensor can measure the intensity of thelight and generates a voltage pattern. Such sensors can measure theemitted ambient light from the test device instead of measuringreflected light of a specific frequency originating from the energysource. In one embodiment, the detector 235 can employ 2-dimensionalimaging for example using a small video camera to capture images. Thistype of imaging can use CCD technology or CMOS sensors. Instead of asingle row of sensors (i.e., one-dimensional detector), atwo-dimensional array of sensors may be employed. This detectorconfiguration may provide a series of two dimensional frames or onedimensional lines that can be provided to the microprocessor todetermine position or registration as well as movement so as to correctthe alignment of the test sample for angle and/or movement.

FIG. 7 illustrates additional details of an embodiment of a device 715and associated electronics elements. Device 715 may correspond withdevices 15 and 215 as shown in FIGS. 1 and 2B. As shown in FIG. 7, acircuit board or other similar or equivalent structure 743 incorporatingelectronics may include a microprocessor 740 (which may correspond tomicroprocessors 40 and 240 of FIGS. 1 and 2A), one or more memorydevices 750, one or more input/output (I/O) devices 730, as well asother electronic elements (not shown for purposes of clarity) as areknown in the art. In general, the microprocessor 740 is communicativelycoupled to memory 787, which may be configured to store instructionscomprising one or more software modules, as well as sample data, userinput(s), output data, and/or other associated data or information. I/Omodule 780 may be configured to electronically couple device 715 withexternal devices, such as external computers or other systems as aredescribed herein. I/O module 780 may include a serial or parallelcommunication element (such as a USB module, firewire module or otherlike module), a wireless communications module (such as a Wi-Fi,Bluetooth or other wireless module), an optical I/O module, or othercommunications module as is known or developed in the art. Device 716may include one or more data ports 785, configured to receive memorystorage devices such as USB devices, SD, CompactFlash, memory stick orother devices.

In addition, device 715 may include one or more display modules 710,such as LEDs, LCDs or other display or indication modules and one ormore user input modules 775, such as pushbuttons, keypads, mice and thelike to receive user inputs. In addition, device 715 may include one ormore detector modules 735, which may correspond with detectors 35 and235, as well as one or more emitter/source modules 725, which maycorrespond with sources 25 and 225.

Attention is now directed to FIG. 6, which illustrates additionaldetails of some embodiments. As shown in FIG. 6, in some embodiments thedevice 215 may include two (or more) detectors 235, 237. The detectors235, 237 can detect different wavelengths of ranges of wavelengths ofenergy. In one embodiment, detector 235 detects wavelengths in the rangeof, for instance, in the infrared, near infrared, ultraviolet andvisible wavelengths. In one embodiment, the wavelengths detected bydetectors 235 and 237 are sufficiently different from the wavelength ofexcitation light emitted from the energy source 225 so as to reducebackground noise. In one embodiment, detector 235 detects wavelengthsfrom a labeled analyte of interest immobilized on the test strip 265 ofthe test device 220 and detector 237 detects wavelengths from indicia270 on the test device 220. The detectors 235, 237 may be configured todetect wavelengths from the labeled analyte as well as wavelengths fromthe indicia 270 in a single pass of the chassis 245 over the diagnosticlane 260. It is to be noted that although in this embodiment onedetector, e.g., 235, detects a wavelength of energy emitted from a labelin its excited form, and another detector, e.g., 237, detects awavelength of energy emitted from the indicia, in some embodiments, asingle detector can be configured for receiving and detecting both awavelength of energy emitted from the label as well as a wavelength ofenergy emitted from the indicia.

Depending on the label used, the excitable energy emitted from theenergy source 225 is at a wavelength that differs from the emittedenergy from the sample excited such that background signals measured bya detector will be minimized. To further improve thesignal-to-background ratio of the system, one or more filters can beincluded such as high-pass filters to cutoff frequencies of the energysource at frequencies below (wavelengths above) the preferred excitationwavelength that could potentially be a source of background for thedetector. A low-pass filter can also be included to cutoff frequenciesof the energy source at frequencies above (wavelengths below) thepreferred detection frequency.

It should be appreciated that the scanning devices described herein caninclude additional energy sources and additional detectors or othercombinations of energy sources and detectors. For example, a detectormay be included that detects other labels from the test device such asfor example barcodes, radio frequency emitters, light energy emitters,electromagnetic wave emitters, magnetic strips, an inductive circuit ora combination thereof. The information provided by such labels mayinclude for example, patient identification, sample identification,sample type, identification of a test to be performed on a sample, or acombination thereof

As shown in FIG. 6, the scanning device 215 includes an optics assembly230. The optics assembly 230 may be configured to direct the energy fromthe energy source 225 towards a test device 220 through the aperture 255in the interface region 250 of the chassis 245. The energy passingthrough the optics assembly 230 is spread over the diagnostic lane 260of the test device 220 such that test lines 267 as well as indicia 270on the test device 220 are energized. A reflectance read as well as afluorescence read may be performed simultaneously in a single pass ofthe scanning device across the test device.

The optics assembly 230 may include one or more filters, lenses, mirrorsand the like. The energy may be directed by the optics assembly 230 atan axis that, in certain embodiments, may be at least about a 90 degreeangle relative to the test device. In one embodiment, the energy emittedfrom the energy source 225 is directed to the test device atapproximately a 45 degree angle. Other angles and alternativeconfigurations may also be used in various embodiments.

The energy source 225 may be positioned such that energy is emittedtoward the test device at a specific angle. In one embodiment, thesource 225 may be positioned at a 90 degree angle to the test device. Inother embodiments, the source 225 may be positioned at an angle that ismore or less than a 90 degree angle with respect to the test device.Similarly, the one or more detectors 235 may receive light from thelabeled analyte and/or the indicia on the test device at a specificangle, for example, an angle more or less than or equal to 90 degreesrelative to the test device.

Filters may be included as part of the optics assembly 230, for examplecut-off or band-pass filters to reduce background. If the energy sourceprovides excitation energy at a particular wavelength, the emittedwavelength may be sufficiently different from the excitation wavelengthto reduce background.

Turning again to FIG. 5, the detector 235 communicates the detectedoptical signals to the microprocessor 240. The microprocessor 240processes the data from the detector 235 into a response or outputsignal. The microprocessor 240 is configured to run one or more softwaremodules that may include data reduction and curve-fitting algorithmssuch that relative movement between the test device and the chassis 245of the scanning device 215 during a read may be detected, compensatedand corrected. For example, corrections can be made for variable speedand dwell time on any particular location of the test device. The angleor relative alignment between the detector 235 and the test device 220can also be corrected. Corrections may be made in one or more planesincluding, for example x-, y- and z-planes.

FIG. 8 illustrates details of reading a test sample on a test strip 265that includes indicia and test lines as shown in FIG. 1. The test strip265 is positioned as described previously herein so that it may bepassed by the detector(s) 235, typically via linear motion in the scandirection. The test strip may be illuminated by a source as describedpreviously herein, such as source 225, so as to emit or reflectelectromagnetic radiation that may then be detected by the detectorelement. In FIG. 8, the test strip is offset at an angle a with respectto the detector; however, by determining the relative positions of theindicias 70, the corresponding alignment of the test strip with respectto detector 235 (and the associated scanner/reader) may be determined byprocessing the detected indicia and/or test lines 267. In addition,speed may likewise be determined by processing the detected indiciaand/or test lines and calculating, based on known parameters such asindicia and/or test line spacing, the relative speed and/or speedvariations in presenting the sample.

FIG. 9 illustrates details of an embodiment of a process 900 forprocessing a test strip 265 such as is shown in FIG. 8. At stage 910,the test sample scan is initiated, with the sample being moved relativeto the detector. As described previously herein, this may be done in anyof several ways. As the test strip is moved across the detector 235, itmay be illuminated by a source such as source 225 so that it emits orreflects a detectable output such as when a target analyte is present.At stage 915, one or more indicia and/or one or more test strips may bedetected by the detector 235. Emissions or reflections from the teststrip may be read in response to detection of an associated indicia as areference location. Emissions or reflections from the indicia may beused to trigger reads of the test strip. The detection may be ofradiation emitted or reflected from the test strip, and may representone, two or three dimensional emission or reflection detection. Thedetected emissions or reflections may be incorporated into a detectionsignal that may then be sent to a processor, such as processor 240.

At stage 920, the positional alignment and/or motion of the test stripmay be determined in one or more software modules. This may be done by,for example, comparing the relative timing of emissions or reflectiondata in the detection signal from the indicia and/or test strips and/ormay be done in one, two or more dimensional processing depending thenature of the signal. Likewise, motion, velocity and/or variations ofthese, as well as other related information, may be determined at stage925 based on the received emissions or reflections from the indicia(s)and/or test strip(s). Correlation of detection signals with indiciareference patterns may be used to implement this stage. A set ofcorrected detection data may be provided as an output of this stage.

At stage 930, the raw detected test strip data may be adjusted based onthe alignment and/or motion determinations and/or corrected detectiondata made in stages 920 and 925 to generate test result output data. Thedata may, for example, be used to adjust the relative level of thereceived test strip emissions based on the motion of the test strip. Inaddition, the adjustment may be used to match test strip data atparticular test lines to reference positioning determined based on theindicia. This may be used to map the test strip results to particulartest samples to provide corresponding output(s). Data associated withmotion detection may also be used to correct for variation in feedspeeds of the sample through the scanner. In some implementations,motion and/or position data detected from the indicia may be used in acontrol or feedback loop to trigger or control emissions from the sourceso at to illuminate the sample at an appropriate time and/or fordetection of sample emissions or reflections at an appropriate time,such as within predefined timing window(s).

At stage 935, the test result output data may be output and/or stored ina memory for further review and/or processing. Output test results mayinclude quantitative data regarding presence or absence of a target oranalyte in the sample. In some embodiments, the test result output datamay be used to provide a test result output provided on a display orother output device. Alternately or in addition, the output may bestored on a memory device via a data port and/or may be provided via anI/O interface to an external device or system.

As noted previously, in typical embodiments, the microprocessor 240 andsoftware modules may also provide a quantitative determination for theassay as an output. For example, a positive or negative result for eachtest line 267 within the testing region 260 can be provided based on aread of the test sample and associated processing of the read in themicroprocessor, such as is described previously herein. For example,detection of a target illumination from a test line 267 may be used asthe basis for a quantitative positive result, and may be adjusted basedon the indicia and/or motion or position determination. In addition,information regarding the concentration of analyte in the sample can beprovided. The information may be correlated such that indicators of riskor presence of a disease or disorder are provided by the scanningdevice. The information may optionally be input into a decision supportsystem and processed to provide an enhanced assessment of the risk of amedical condition. In addition, information from the test may beprovided on a display of the device 215, either in a visual or audiblefashion, or both.

The microprocessor 240 may also control specific operations of thescanning device 215 and control of the various functionalities of thedevice 215, including mechanical, optical and/or electronicfunctionality. The microprocessor 240 may be a central processor thatcontrols the functionality through a bus structure or othercommunications interface. The microprocessor 240 may be implemented bydistributing the processing functions amongst one or more of the variouscomponents of the scanning device. As noted previously, themicroprocessor 240 may comprise one or more physical devices such asmicroprocessors, microcontrollers, DSP devices, ASICS, FPGAs or otherprogrammable devices as are known or developed in the art. Themicroprocessor 240 may further incorporate memory to store data and/orinstructions to perform the functions as described herein, as well asothers.

The scanning device 215 may be provided with additional functionalfeatures including, for example, a user interface 275, communicationmodule 280, data port 285, memory 287, power supply 290, alignmentsystem 257, and light shield 259 each to be described in more detailbelow. Any or all of these functionalities may be included in thescanning device 215 as is appropriate for the desired use.

The user interface 275 may be used for operating the device and viewingthe results. The user interface 275 may include, for example, a keypadand/or display such as a small monochromatic or color LCD display. Theuser interface 275 may include technology that allows for the user totouch and select appropriate settings for use of the device such as atouch-screen display. Alternative interfaces may be provided as well,for example, a keyboard, mouse, track ball, or other user interfacedevices.

A data port 285 may be used with the scanning device 215. The data port285 may be a ROM chip socket configured to receive a removable ROM chipor a SD type memory card slot configured to receive a memory card or thelike. The data port 285 and associated storage devices can be used tostore and/or backup data or lot-specific method parameters, updatesoftware, store program instructions, control and calibrate curves,operational data, history logs and other information that may be usedwith the device 215. The data port 285 and associated storage devicesmay be used for saving results in order to transfer the information toan information system such as a laboratory information system (LIS) orsystem personal computer (PC) or the like. The device may also include acommunication module 280 that can transmit such information from thedevice to an LIS or PC. The communication module 280 may be wired or awireless transmitter, a Bluetooth, bi-directional communicationsinterface, infrared interface, RS-232 interface, RF interface, networkinterface or other communications interface. Information transmitted caninclude test results, statistics and other information as well as thereceipt of information and instructions from external sources.

The memory 287 may be used to provide storage for program data or otherdata used by the microprocessor 240 during operation of the device 215.The memory 287 may be implemented using various RAM or ROM memorydevices. The memory 287 may be used to store operating instructions andto provide memory registers for operating and storage. Memory 287 mayalso be used in conjunction with the data port 285 and associatedstorage devices. The memory 287 is generally used to store only datathat is accessed frequently or rapidly.

The scanning device 215 may also include a power supply 290. The powersupply 290 can include batteries, solar cells, transformers used toconvert an AC power source or other techniques to provide theappropriate power levels to the components of the device 215. In anembodiment, the power supply 290 can be rechargeable batteries such as,for example, NiCad or Nickel Metal Hydride batteries which can berecharged using a charger connected to AC power from a conventional walloutlet. The power supply 290 may be associated with a button 277 orother mechanism that a user can actuate in order to activate the powersupply 290 and turn on the device 215.

As shown in FIGS. 3 and 2A-2D, in one embodiment the scanning device 215may include an alignment system 257. The alignment system 257 can beused to assist in scanning a test device having corresponding alignmentfeatures 272 as shown in FIG. 5A. The alignment system 257 may be, forexample, a pair of parallel rails positioned on either end of theaperture 255 near the interface region 250 of the device 215. Thealignment system 257 can, for example, slideably interface withcorresponding alignment features 272 present on the surface of the testdevice 220. The alignment features 272 of the test device 220 can be,for example, a pair of longitudinal channels. Alternatively, thealignment features 272 of the test device 220 can include raised tracksover which the alignment features 272 of the scanning device 215 can useas a guide during a swipe (see FIG. 2D). The configuration of thealignment system 257 and corresponding alignment features 272 can vary.

A light shield 259 may also be attached to the interface region 250 ofthe scanning device 215 (see FIG. 2B). The light shield 259 surroundsthe interface region 250 and the aperture 255 of the device 215 on oneor more sides. The light shield 259 as well as the alignment system 257may block ambient light from entering the device 215 or the diagnosticlane 260 of the test device 220 during use. The alignment system 257 andlight shield 259 can be integral with the chassis 245 or modular suchthat they couple to the distal portion of the device 215 near theinterface region 250.

EXAMPLE WORK FLOW AND METHODS

It should be appreciated that a sample collection device (SCD) maylikewise be included in the diagnostic assay systems described herein.In general, a sample can be processed using a SCD which prepares asample for application to a test device and reading a result via ascanner. For example, in some embodiments, a sample may be obtained oradded to a SCD and one or more analytes contacted with reagents presentin the SCD (e.g., detection and capture probes, and/or extractionreagents). The sample can then be processed and transferred through theSCD to the test device and read with a scanner.

For example, the sample mixture may enter the test device as is known inthe art. The sample can be driven by capillary force and/or by washbuffer comprised in the test device so as to allow any analyte-probecomplex to pass through the lateral flow membrane contained in the testdevice. Capture probes and complementary immobilized capture moietiesbind or hybridize to each other in predetermined lines or spots on thelateral flow membrane, whereby detection probes (via conjugate labelscontained thereon) will provide a detectable signal which cansubsequently be read to determine which analytes were present in thesample processed.

Subsequently, the test device may be read with a scanning device todetect presence of a detectable signal at one or more defined linesand/or indicia on the test device. To read the test lines with boundanalyte, the user holds the chassis of the scanning device and swipes itover the diagnostic lane of the test device with the interface regionpointing towards the test strip. The test device can be read in a singlepass over the diagnostic lane or more than one pass over the testdevice. The test device and scanning device are freely movable relativeto each other, meaning the scanning device can be freely moved by theuser's hand with respect to the test device and vice versa. In certainembodiments, the test device is not inserted or loaded into the scanningdevice.

Information regarding the analyte of interest, indicators of risk,presence of a disease or disorder, patient information, test informationmay be provided upon swiping the scanning device over the test device.The information may optionally be input into a decision support systemand processed to provide an enhanced assessment of the risk of a medicalcondition. The scanning device can automatically display, print, save orupload the results. The scanning devices described herein are designedto have simple controls and a user interface such that assays are readand recorded without needing interpretation.

It should be appreciated that the scanner may be incorporated into akit. In an embodiment, the kit may include one or more test devices anda hand-held scanner. In an embodiment, the kit further includes a samplecollection device.

As certain changes may be made without departing from the scope of thepresent subject matter described herein, it is intended that all mattercontained in the above description or shown in the accompanying drawingsbe interpreted as illustrative and not in a literal sense (and thus, notlimiting). Practitioners of the art will realize that the method, deviceand system configurations depicted and described herein are examples ofmultiple possible system configurations that fall within the scope ofthe current subject matter described herein.

While the subject matter described herein has been described withreference to the specific embodiments thereof, it should be understoodby those skilled in the art that various changes may be made andequivalents may be substituted without departing from the true spiritand scope of the subject matter described herein. In addition, manymodifications may be made to adapt a particular situation, material,composition of matter, process, process step or steps, to the objectiveand scope of the subject matter described herein. All such modificationsare intended to be within the scope of the claims appended hereto.

Throughout this application, various publications, patents and publishedpatent applications may be cited. The disclosures of these publications,patents and published patent applications referenced in this applicationare hereby incorporated by reference in their entirety into the presentdisclosure. Citation herein by the Applicant of a publication, publishedpatent application, or patent is not an admission by the Applicant ofsaid publication, published patent application, or patent as prior art.Accordingly, all publications and patents cited in this specificationare herein incorporated by reference as if each individual publicationor patent were specifically and individually indicated to beincorporated by reference.

While this specification contains many specifics, these should not beconstrued as limitations on the scope of an invention that is claimed orof what may be claimed, but rather as descriptions of features specificto particular embodiments. Certain features that are described in thisspecification in the context of separate embodiments may also beimplemented in combination in a single embodiment. Conversely, variousfeatures that are described in the context of a single embodiment mayalso be implemented in multiple embodiments separately or in anysuitable sub-combination. Moreover, although features may be describedabove as acting in certain combinations and even initially claimed assuch, one or more features from a claimed combination may in some casesbe excised from the combination, and the claimed combination may bedirected to a sub-combination or a variation of a sub-combination.Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults.

In one or more exemplary embodiments, the functions, processes andmethods described herein may be implemented in hardware, software,firmware, or any combination thereof. If implemented in software, thefunctions may be stored on or encoded as one or more instructions orcode on a computer-readable medium. Computer-readable media includescomputer storage media. Storage media may be any available media thatmay be accessed by a computer. By way of example, and not limitation,such computer-readable media can comprise RAM, ROM, EEPROM, CD-ROM orother optical disk storage, magnetic disk storage or other magneticstorage devices, or any other medium that can be used to carry or storedesired program code in the form of instructions or data structures andthat can be accessed by a computer. Disk and disc, as used herein,includes compact disc (CD), laser disc, optical disc, digital versatiledisc (DVD), floppy disk and blu-ray disc where disks usually reproducedata magnetically, while discs reproduce data optically with lasers.Combinations of the above should also be included within the scope ofcomputer-readable media.

It is understood that the specific order or hierarchy of steps or stagesin the processes disclosed is an example of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged while remainingwithin the scope of the present disclosure. Accompanying method claimsmay present elements of the various steps in a sample order, and are notmeant to be limited to the specific order or hierarchy presented.

Those of skill in the art would understand that information and signalsmay be represented using any of a variety of different technologies andtechniques. For example, data, instructions, commands, information,signals, bits, symbols, and chips that may be referenced throughout theabove description may be represented by voltages, currents,electromagnetic waves, magnetic fields or particles, optical fields orparticles, or any combination thereof

Those of skill would further appreciate that the various illustrativelogical blocks, modules, circuits, and algorithm steps described inconnection with the embodiments disclosed herein may be implemented aselectronic hardware, computer software, or combinations of both. Toclearly illustrate this interchangeability of hardware and software,various illustrative components, blocks, modules, circuits, and stepshave been described above generally in terms of their functionality.Whether such functionality is implemented as hardware or softwaredepends upon the particular application and design constraints imposedon the overall system. Skilled artisans may implement the describedfunctionality in varying ways for each particular application, but suchimplementation decisions should not be interpreted as causing adeparture from the scope of the present disclosure.

The various illustrative logical blocks, modules, and circuits describedin connection with the embodiments disclosed herein may be implementedor performed with a general purpose processor, a digital signalprocessor (DSP), an application specific integrated circuit (ASIC), afield programmable gate array (FPGA) or other programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof designed to perform the functions described herein.A general purpose processor may be a microprocessor, but in thealternative, the processor may be any conventional processor,controller, microcontroller, or state machine. A processor may also beimplemented as a combination of computing devices, e.g., a combinationof a DSP and a microprocessor, a plurality of microprocessors, one ormore microprocessors in conjunction with a DSP core, or any other suchconfiguration.

The steps of a method or algorithm described in connection with theembodiments disclosed herein may be embodied directly in hardware, in asoftware module executed by a processor, or in a combination of the two.A software module may reside in RAM memory, flash memory, ROM memory,EPROM memory, EEPROM memory, registers, hard disk, a removable disk, aCD-ROM, or any other form of storage medium known in the art. Anexemplary storage medium is coupled to the processor such the processorcan read information from, and write information to, the storage medium.In the alternative, the storage medium may be integral to the processor.The processor and the storage medium may reside in an ASIC. The ASIC mayreside in a user terminal In the alternative, the processor and thestorage medium may reside as discrete components in a user terminal

The previous description of the disclosed embodiments is provided toenable any person skilled in the art to make or use the presentdisclosure. Various modifications to these embodiments will be readilyapparent to those skilled in the art, and the generic principles definedherein may be applied to other embodiments without departing from thespirit or scope of the disclosure. Thus, the present disclosure is notintended to be limited to the embodiments shown herein but is to beaccorded the widest scope consistent with the principles and novelfeatures disclosed herein.

The claims are not intended to be limited to the aspects shown herein,but is to be accorded the full scope consistent with the language of theclaims, wherein reference to an element in the singular is not intendedto mean “one and only one” unless specifically so stated, but rather“one or more.” Unless specifically stated otherwise, the term “some”refers to one or more. A phrase referring to “at least one of” a list ofitems refers to any combination of those items, including singlemembers. As an example, “at least one of: a, b, or c” is intended tocover: a; b; c; a and b; a and c; b and c; and a, b and c.

It is intended that the following claims and their equivalents definethe scope of the invention.

We claim:
 1. A diagnostic assay system comprising: a test deviceincluding a test strip having one or more test lines and one or moreindicia, and a scanning device comprising: i) a source ofelectromagnetic radiation; ii) an optics assembly disposed to direct theelectromagnetic radiation; iii) a detector disposed to receive anemission or reflection from the test strip, wherein: the detector is asingle detector configured to detect the emission or reflection from theone or more test lines and emission or reflection from the one or moreindicia; or the detector comprises a first detector configured to detectthe emission or reflection from the one or more test lines and a seconddetector configured to detect the emission or reflection from the one ormore indicia; iv) a microprocessor; and v) a chassis; wherein the testdevice and scanning device are configured to be movable relative to eachother during operation of the scanning device and wherein themicroprocessor is configured to generate test result data based at leastin part on the indicia and one or more of the test lines.
 2. The systemof claim 1, wherein the indicia are positioned adjacent to the one ormore test lines such that each indicia corresponds with a test line. 3.The system of claim 1, wherein the test device further comprises a bodyhaving a window, wherein the body is configured so that the one or moretest lines may be exposed to an output from the source through thewindow.
 4. The system of claim 1, wherein the detector is a singledetector configured to detect an emission or radiation from the one ormore test lines and from the one or more indicia.
 5. The system of claim1, wherein the test device and scanning device are configured to befreely movable relative to each other in at least one plane.
 6. Thesystem of claim 1, wherein the chassis is configured as a hand-heldchassis and further comprises a test device interface near a distalregion of the chassis.
 7. The system of claim 6, further comprising ashield coupled to the test device interface, wherein the shield isconfigured to surround an aperture of the scanning device such that theshield blocks ambient light from entering the scanning device throughthe aperture.
 8. The system of claim 6, wherein the hand-held chassiscomprises parallel rails extending distally from the distal region ofthe chassis near the test device interface.
 9. The system of claim 8,wherein the test device comprises a pair of longitudinal channels shapedto receive the parallel rails of the hand-held chassis.
 10. The systemof claim 1, wherein the microprocessor is configured to generate thetest result data so as to compensate for relative movement between thetest device and the scanning device.
 11. The system of claim 10, whereinthe compensation includes compensation for variable speed during therelative movement between the test device and the scanning device. 12.The system of claim 1, wherein the microprocessor is configured togenerate the test result data so as to compensate for a relative angularoffset between the test strip and the scanning device.
 13. The system ofclaim 1, wherein the test lines have immobilized thereto a capturemoiety.
 14. The system of claim 1, wherein the test device includes asubstrate, and the substrate further comprises one or more controllines.
 15. The system of claim 1, wherein the detector comprises acharge couple device (CCD).
 16. A method of assaying a sample to detectan analyte of interest, the method comprising the steps of: providing asample from a sample collection device to a test device, wherein thetest device comprises one or more test lines having immobilized theretoa capture moiety specifically binding directly or indirectly one or moreanalytes of interest, and wherein one or more indicia are positioned ona surface of the test device adjacent the one or more test lines; movingthe test device relative to a scanning device; reading one or more ofthe test lines and one or more of the indicia, said reading furthercomprising: detecting emission or reflection from the one or more testlines and from the one or more indicia at a single detector of thescanning device; or detecting emission or reflection from the one ormore test lines at a first detector of the scanning device and detectingemission or reflection from the one or more indicia at a second detectorof the scanning device; generating test result data based at least inpart on the reading; and storing the test result data in a memory. 17.The method of claim 16, wherein at least one of the single detector, thefirst detector, and the second detector is a charge couple device (CCD).